クリニカルサイエンティスト【オンコロジー他担当領域選択可能!】

Job Details

<求人タイトル>

15261 クリニカルサイエンティスト【オンコロジー他担当領域選択可能!】

<職務内容>

Position Summary / Objective:
・Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
・May serve as Clinical Trial Lead for one or more trials
・May lead or support trial level activities for one or more trials with the necessary supervision
・May co-lead study team meetings in partnership with GDO/RCO protocol manager and collaborate with cross-functional study team members
Position Responsibilities::
・Collaborate and liaise with external partners (e.g., KO Ls)
・Seek out and enact best practices with instruction
・Provide regular and timely updates to manager/management as requested
・Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
・Conduct literature review
・Submit clinical documents to TMF
・Develop site and CRA training materials and present these at SIVs and Investigator meetings
・Review clinical narratives
・Monitor clinical data for specific trends; provide trends and escalate questions to Japan Clinical Trial Physician
・Develop Data Review Plan in collaboration with Data Management
・Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
・Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, HA, EC, IRB responses and contribute to regulatory submission.)

<応募要件>

Experience Requirements:
・Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
・Ability to understand assigned protocol(s) and their requirements
・Basic knowledge skills to support program-specific data review and trend identification
・Intermediate medical writing skills and medical terminology
・Basic planning/project management skills (develop short range plans that are realistic and effective)
・2-3 years experience in Industry in a Clinical research or relevant environment
Key Competency Requirements:
・Detail-oriented with commitment to quality
・Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
・Intermediate critical thinking and problem-solving skills
・Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism

<会社概要>

オンコロジー・ヘマトロジー・再生医療領域等に注力する大手外資系スペシャリティファーマです。再生医療を含めて今後も更なるビジネスの拡大が見込まれている企業になります。スピード感にあふれ意思決定がとても早く、新しいことにどんどんチャレンジをしていきたい方にとって、とても魅力的な会社です。働きやすい環境も整っており、コアタイムなしのスーパーフレックス制度、在宅勤務制度もございます。

<注目ポイント>

グローバルや国内の臨床開発部門と協力して、試験のICFやプロトコルの立案、試験のデザイン等一連の準備に参画していただきます。スタディーマネージャーやトライアルマネージャーとしてプロトコルを書いたご経験、メディカルライティングとして薬事部門でのライティングだけではなく試験のプロトコルを書いたご経験、PMDAとのコミュニケーション・交渉をしたご経験などを活かしていただけます。様々なファンクションのチームと一緒に一つの目標に向かって協業をしていきたい方におすすめのポジションです!担当するプロトコルも複数となるため短期間でのキャリアアップが見込めるうえ、現在主要パイプラインの中で担当領域の選択が可能です!ご興味がございましたら、是非お早めにお問い合わせください。

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company